Back to resultsA 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria:
- Male or female child 4-5 years of age at screening.
- Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable).
- Meets DSM-5 criteria for ADHD based on the K-SADS-PL.
- ADHD RS-IV Preschool-Home Version score at Screening and Baseline >/= 90th percentile for gender and age in >/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score.
- Peabody Picture Vocabulary Test 4 (PPVT-4)Standard Score >/=70.
- Child Global Assessment Scale (CGAS) score </= 55.
- Participation in a school type program (day care, preschool, kindergarten, transitional kindergarten, or elementary school) for at least >/=2 half days of the week for at least 3 months and that is anticipated to continue during the study.
- History of an adequate course of non medication treatment for ADHD based on investigator judgment or, where such treatments are not available, the severity of the subject's ADHD symptoms are such that medication treatment is deemed necessary by the investigator
Exclusion Criteria:
- Treated with atomoxetine within 30 days prior to the Baseline.
- Received any investigational products or devices within 30 days prior to the Baseline visit.
- History of stimulant nonresponse, intolerability or hypersensitivity to any dose of methylphenidate or other stimulant. If a known allergy to D&C red #30, he/she should not be enrolled in the study.
- An intelligence quotient (IQ) <70.
- History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
- Less than 5th percentile for height or weight at Screening.
- History of recent clinically significant self-harming behaviors.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Methylphenidate Hydrochloride Extended Release Chewable Tablet
Arm Description
one chewable tablet once daily in morning.
one chewable tablet once daily in morning.
Outcomes
Primary Outcome Measures
Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
Change from Baseline to end of double-blind treatment in the total score of the Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
Secondary Outcome Measures
Safety-incidence of treatment emergent adverse events
incidence of treatment emergent adverse events
Change from Baseline in Clinical Global Impression - Severity (CGI-S) score
The CGI-S is a one-item scale for the clinician to assess their impression of the severity of a subject's current state of illness relative to clinician's past experience with patients who have the same diagnosis. A subject's severity of mental illness is assessed considering a clinician's total clinical experience using a scale from 1 to 7 defined as: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.
Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score
The CGI-I is a one-item scale to compare the subject's current condition to the condition at the Baseline (Day -1) visit using a scale from 1 to 7 defined as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
ADHD RS-IV Preschool-Home Version Total score
The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often.
ADHD RS-IV Preschool-Home Version hyperactivity and inattention subscales scores
The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often.
ADHD RS-IV Preschool-School Version Total score
The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.
ADHD RS-IV Preschool-School Version hyperactivity and inattention subscales scores
The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03536390
Brief Title
A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
Official Title
A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The study was cancelled prior to the enrollment of any participants.
Study Start Date
September 19, 2018 (Anticipated)
Primary Completion Date
April 22, 2021 (Anticipated)
Study Completion Date
April 22, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This 6-week study is to determine if the study drug, Methylphenidate Hydrochloride (HCl) Extended-Release Chewable Tablets (ERCT), is safe, tolerable and effective when compared to a sugar pill or placebo in children 4 to 5 years of age with ADHD.
Detailed Description
Phase 4 Double-blind, Randomized, Parallel Group, Placebo-controlled Study of the Efficacy And Safety of Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, placebo-controlled, parallel group study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
one chewable tablet once daily in morning.
Arm Title
Methylphenidate Hydrochloride Extended Release Chewable Tablet
Arm Type
Experimental
Arm Description
one chewable tablet once daily in morning.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
Intervention Description
Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
Description
Change from Baseline to end of double-blind treatment in the total score of the Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
Time Frame
Basline, 6 Weeks
Secondary Outcome Measure Information:
Title
Safety-incidence of treatment emergent adverse events
Description
incidence of treatment emergent adverse events
Time Frame
6 Weeks
Title
Change from Baseline in Clinical Global Impression - Severity (CGI-S) score
Description
The CGI-S is a one-item scale for the clinician to assess their impression of the severity of a subject's current state of illness relative to clinician's past experience with patients who have the same diagnosis. A subject's severity of mental illness is assessed considering a clinician's total clinical experience using a scale from 1 to 7 defined as: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.
Time Frame
Baseline, Weeks 1 through 6
Title
Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score
Description
The CGI-I is a one-item scale to compare the subject's current condition to the condition at the Baseline (Day -1) visit using a scale from 1 to 7 defined as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Time Frame
Baseline, Weeks 1 through 6
Title
ADHD RS-IV Preschool-Home Version Total score
Description
The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often.
Time Frame
Weeks 1 through 5
Title
ADHD RS-IV Preschool-Home Version hyperactivity and inattention subscales scores
Description
The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often.
Time Frame
Weeks 1 through 6
Title
ADHD RS-IV Preschool-School Version Total score
Description
The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.
Time Frame
Weeks 3 and 6
Title
ADHD RS-IV Preschool-School Version hyperactivity and inattention subscales scores
Description
The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.
Time Frame
Weeks 3 and 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
69 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female child 4-5 years of age at screening.
Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable).
Meets DSM-5 criteria for ADHD based on the K-SADS-PL.
ADHD RS-IV Preschool-Home Version score at Screening and Baseline >/= 90th percentile for gender and age in >/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score.
Peabody Picture Vocabulary Test 4 (PPVT-4)Standard Score >/=70.
Child Global Assessment Scale (CGAS) score </= 55.
Participation in a school type program (day care, preschool, kindergarten, transitional kindergarten, or elementary school) for at least >/=2 half days of the week for at least 3 months and that is anticipated to continue during the study.
History of an adequate course of non medication treatment for ADHD based on investigator judgment or, where such treatments are not available, the severity of the subject's ADHD symptoms are such that medication treatment is deemed necessary by the investigator
Exclusion Criteria:
Treated with atomoxetine within 30 days prior to the Baseline.
Received any investigational products or devices within 30 days prior to the Baseline visit.
History of stimulant nonresponse, intolerability or hypersensitivity to any dose of methylphenidate or other stimulant. If a known allergy to D&C red #30, he/she should not be enrolled in the study.
An intelligence quotient (IQ) <70.
History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
Less than 5th percentile for height or weight at Screening.
History of recent clinically significant self-harming behaviors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491017&StudyName=A+Multi-center%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+Evaluating+The+Safety+And+Efficacy+Of+Quillivant+Xr+In+The+Treatment+Of+Pre-school+Aged+Children+With+Adhd
Description
To obtain contact information for a study center near you, click here.
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491017&StudyName=A+Phase+4%2C+Double-blind%2C+Randomized%2C+Parallel+Group%2C+Placebo-controlled+Study+Of+The+Efficacy+And+Safety+Of+Quillichew+Extended+Release+Chewable+Tablets+%28methylphenidate+Hcl+Extended+Release+Chewable+Tablets+%28erct%29%29++In+4-5+Year+Old+Children+With+Attention+Deficit+Hyperactivity+Disorder+%28adhd%29.
Description
To obtain contact information for a study center near you, click here.
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491017&StudyName=A+Phase+4%2C+Double-blind%2C+Randomized%2C+Parallel+Group%2C+Placebo-controlled+Study+Of+The+Efficacy+And+Safety+Of+Quillichew+%28methylphenidate+Hydrochloride+%28hcl%29%29+Extended+Release+Chewable+Tablets+%28erct%29+In+4-5+Year+Old+Children+With+Attention+Deficit+Hyperactivity+Disorder+%28adhd%29
Description
To obtain contact information for a study center near you, click here.
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491017&StudyName=A+Phase+4%2C+Double-blind%2C+Randomized%2C+Parallel+Group%2C+Placebo-controlled+Study+Of+The+Efficacy+And+Safety+Of+Methylphenidate+Hydrochloride+%28hcl%29+Extended+Release+Chewable+Tablet+%28erct%29+In+4-5+Year+Old+Children+With+Attention+Deficit+Hyperactivity+Disorder+%28adhd%29
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
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